Through the 510K clearance process, a host of medical devices considered to be “moderate risk” or Class II devices have been implanted in patients without the FDA investigating or approving the safety of these products. The 510K clearance process does not require that medical devices undergo clinical trials involving humans before they are approved.
Rather, the FDA makes a determination that the product was found to be “substantially equivalent” to preexisting products on the market. This process allows medical device companies to produce and market what the industry calls a “me too” product.
For example, a host of transvaginal mesh devices were approved for urogyenocologic procedures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) under the FDA’s 510(k) approval process.
In 1996, Boston Scientific won FDA approval for a device called a vaginal sling, marketed under the name ProteGen, to treat feminine stress urinary incontinence (SUI). Two years later, Johnson & Johnson won FDA clearance for a similar device called the Gynecare TVT. Under the 510(k) clearance process, Johnson & Johnson was not required to conduct human clinical trials because the company claimed that its sling device was “substantially equivalent” to the ProteGen sling.
In 1999, Boston Scientific voluntarily recalled its ProteGen vaginal sling, stating that it had received reports of erosion of the mesh tissue, infection, discharge, painful sexual intercourse and other complications which may require the removal of the device and additional surgeries. However, Johnson & Johnson has not recalled the Gynecare TVT device and it is still on the market. The TVT device became the predicate device for the IVS Tunneller, which in turn became a predicate device for another mesh and so on. Transvaginal surgical meshes and slings on the market trace their roots back to the recalled ProteGen sling.
Significantly, in September 2011, the FDA staff proposed that transvaginal mesh devices be reclassified and placed in the agency’s highest risk category, Class III.